Anchor and anchor deployment apparatus

ABSTRACT

An anchor deployment apparatus for deploying an anchor about a therapy delivery element, such as a lead or a catheter, includes an anchor receiving element having an elongate member defining a lumen. The lumen is configured to slidably receive at least a portion of the therapy delivery element. The anchor is disposable about the elongate member. The deployment apparatus further includes an anchor engagement apparatus having an anchor engagement feature and a channel in which the elongate member of the anchor receiving element is moveable. The engagement feature is configured to engage the anchor when the anchor is disposed about the elongate member, and to cause the anchor to move distally along the elongate member when the feature is engaged with the anchor and the elongate member is moved proximally relative to the engagement element.

RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 13/548,003, filed Jul. 12, 2012, and which is a continuation of U.S.patent application Ser. No. 12/056,547, filed Mar. 27, 2008, issued asU.S. Pat. No. 8,262,624 on Sep. 11, 2012, which the disclosures of whichare hereby incorporated herein by reference.

FIELD

This disclosure relates, inter alia, to implantable medical devices.More particularly, it relates to anchors, anchor deployment apparatuses,and methods for retaining a therapy delivery element, such as a catheteror lead, relative to a position of a patient in which the element isimplanted.

BACKGROUND

Implantable medical catheters and leads have been employed for a varietyof therapeutic and diagnostic purposes. Controlled placement of suchtherapy delivery elements within in a patient is highly desirable, asprecise placement may result in improved therapeutic efficacy or reducedside effects. However, the location of the delivery element may changein time. As the patient moves, the location of the implanted deliveryelement may move.

Anchors, which are typically placed about the delivery element andsutured to subcutaneous tissue of the patient, are employed to securethe position of a delivery region, e.g. infusion section or electrode,of the delivery element; e.g. catheter or lead, relative to a targetlocation of the patient. However, existing anchors may suffer from oneor more drawbacks, including (i) ineffective gripping of an implantedtherapy delivery element when subjected to stresses associated patientmovement, (ii) awkward techniques for placing the anchor about thedelivery element or for suturing the anchor to tissue, and (iii)susceptibility damage during suturing.

SUMMARY

The present disclosure describes, inter alia, anchors, anchor deploymentapparatuses, kits, systems and methods that provide for effectivegripping of a therapy delivery element, simple delivery of an anchor, orprotection of the delivery element during suturing.

In an embodiment, an anchor for maintaining a portion of a therapydelivery element within a desired location of a patient is described.The therapy delivery element has an outer diameter and an outer surfaceabout which the anchor is disposable. The anchor includes (i) a firstopening, (ii) a second opening, (iii) a body member formed from elasticmaterial disposed between the first and second opening, (iv) a lumenextending though the body member from the first opening to the secondopening, and (v) a retention element secured to or integrally formedwith the body member for retaining the anchor within a tissue locationof a patient. The lumen is configured to be disposed about at least aportion of the outer surface of the therapy delivery element. At least aportion of the body member has a first inner diameter defined by thelumen in a relaxed state and a second inner diameter defined by thelumen in a radially stretched state. The first inner diameter is smallerthan the second inner diameter. The first inner diameter is configuredto be smaller than the outer diameter of the therapy delivery element,and the second inner diameter is configured to be larger than the outerdiameter of the therapy delivery element.

In an embodiment, an anchor deployment apparatus for deploying an anchorabout a therapy delivery element is described. The anchor deploymentapparatus includes an anchor receiving element having an elongate memberwith a distal opening and a lumen extending proximally in the elongatemember from the distal opening. The lumen of the elongate member isconfigured to slidably receive at least a portion of a therapy deliveryelement. The anchor deployment apparatus further includes an anchorengagement element having (i) a first channel in which the elongatemember of the anchor receiving element is axially movable, and (ii) anengagement feature forming at least a part of the channel. Theengagement feature is configured to engage the anchor when the anchor isdisposed about the elongate member and the elongate member is moveddistally relative to the engagement element, and to cause the anchor tomove distally along the elongate member when the feature is engaged withthe anchor and the elongate member is moved distally relative to theengagement element.

In an embodiment, a system is described. The system includes an anchorhaving a first opening, a second opening, a body member disposed betweenthe first and second opening, and a lumen extending though the bodymember from the first opening to the second opening. The body member isformed from an elastic material, and at least a portion of the bodymember has a first inner diameter defined by the lumen in a relaxedstate and a second inner diameter defined by the lumen in a radiallystretched state. The first inner diameter is smaller than the secondinner diameter. The system further includes a therapy delivery elementhaving an outer diameter and an outer surface about which the anchor isdisposable. The outer diameter is larger than the first inner diameterof the at least a portion of the lumen of the anchor and smaller thanthe second inner diameter of the at least a portion of the lumen of theanchor. The system also includes an anchor deployment apparatusincluding an anchor receiving element. The anchor receiving element hasan elongate member with a distal opening and a lumen extendingproximally in the elongate member from the distal opening. The lumen ofthe elongate member is configured to slidably receive at least a portionof the therapy delivery element. The elongate member has an outerdiameter larger than the first inner diameter of the at least a portionof the lumen of the anchor and smaller than the second inner diameter ofthe at least a portion of the lumen of the anchor such that the anchoris disposable about the elongate member and, when the anchor is disposedabout the elongate member, the at least a portion of the lumen of theanchor engages at least a portion of the elongate member. The anchor ismoveable about the elongate member and deployable about the therapydelivery element.

By providing anchors, anchor deployment apparatuses, kits, systems andmethods that provide for effective gripping of a therapy deliveryelement, simple delivery of an anchor, or protection of the deliveryelement during suturing, therapeutic efficacy may be enhanced orcomplications may be reduced. These and other advantages will be readilyunderstood from the following detailed descriptions when read inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic drawing of a diagrammatic representation of aperspective view of an environment of an implantable medical system in apatient.

FIGS. 2A-D are schematic drawings of diagrammatic representations ofperspective views of environments of medical devices implanted inpatients.

FIG. 3A is a schematic drawing of a top view of an anchor.

FIG. 3B is a schematic drawing of a cross-section of the anchor in FIG.3 a taken through line 3 b-3 b.

FIGS. 3C-D are schematic drawings of head on back and front views of theanchor of FIG. 3A, as viewed along lines 3 c and 3 d, respectively.

FIG. 4A is a schematic drawing of a top view of a representative systemincluding an anchor, anchor receiving element, and a therapy deliveryelement.

FIG. 4B is a schematic drawing of a cross section taken through line 4b-4 b of FIG. 4A.

FIG. 4C is a schematic drawing of an exploded top view of the system ofFIG. 4A.

FIGS. 4D-E are a schematic drawings of head on front and back views ofthe anchor receiving element depicted in FIG. 4 c as viewed along lines4 d and 4 e, respectively.

FIGS. 5A-B are schematic drawings of a representative system showingdeployment of an anchor from about an anchor receiving element to abouta therapy delivery element.

FIG. 5C is a schematic drawing of a cross section of an anchor disposedabout a therapy delivery element taken along line 5 c-5 c of FIG. 5B.

FIG. 6A is a schematic drawing of a top view of a system including ananchor, a therapy delivery element, and an anchor deployment apparatusthat includes an anchor receiving element and an anchor engagementelement.

FIG. 6B is a schematic drawing of an exploded top view of the systemdepicted in FIG. 6A.

FIG. 6C is a schematic drawing of an exploded side view of the anchorengagement element and anchor receiving element shown in FIG. 6A.

FIG. 6D is a schematic drawing of an opposing side view (relative toFIG. 6C) of the anchor engagement element shown in FIG. 6C.

FIG. 6E is a schematic drawing of a cross section taken along line 6 e-6e of FIG. 6A.

FIG. 6F is a schematic drawing of a cross section taken along line 6 f-6f of FIG. 6A.

FIG. 6G is a schematic drawing of an alternative embodiment of a crosssection taken along line 6 e-6 e of FIG. 6A.

FIGS. 7A-C are schematic diagrams of top views of a system showing ananchor engagement element employed to move an anchor along an anchorreceiving element and onto and about a therapy delivery element.

FIG. 8 is a schematic drawing of a side view of a longitudinal sectiontaken along line 8-8 of FIG. 7B.

FIG. 9A is a schematic diagram of a side view of an anchor engagementelement.

FIG. 9B is a schematic drawing of a top view of a longitudinal sectionof the anchor engagement element taken at line 9 b-9 b of FIG. 9A.

FIG. 10 is a schematic drawing of a top view of components of a kit.

FIGS. 11A-C are schematic drawings of top views of a system including ananchor, an insertion element, and an anchor receiving element.

FIG. 12 is a cross section of an anchor diposed about an insertionelement taken along line 12-12 of FIG. 11.

The drawings are not necessarily to scale. Like numbers used in thefigures refer to like components, steps and the like. However, it willbe understood that the use of a number to refer to a component in agiven figure is not intended to limit the component in another figurelabeled with the same number. In addition, the use of different numbersto refer to components is not intended to indicate that the differentnumbered components cannot be the same or similar.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings that form a part hereof, and in which are shown byway of illustration several specific embodiments of devices, systems andmethods. It is to be understood that other embodiments are contemplatedand may be made without departing from the scope or spirit of thepresent invention. The following detailed description, therefore, is notto be taken in a limiting sense.

All scientific and technical terms used herein have meanings commonlyused in the art unless otherwise specified. The definitions providedherein are to facilitate understanding of certain terms used frequentlyherein and are not meant to limit the scope of the present disclosure.

As used herein, “diameter” means a cross sectional distance from onelocation of a structure to a generally opposition location of thestructure, and is not necessarily limited to circular cross sections.For example, a lumen may have a square, circular, oval, rectangular, orany other cross-sectional shape. Accordingly, it will be understood that“radially stretchable” means expandable such that a cross-sectional areais increasable, and is also not limited to cylindrically shapedstructures.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” encompass embodiments having pluralreferents, unless the content clearly dictates otherwise. As used inthis specification and the appended claims, the term “or” is generallyemployed in its sense including “and/or” unless the content clearlydictates otherwise.

The present disclosure describes, inter alia, anchors, anchor deploymentapparatuses, kits, systems and methods that provide for effectivegripping of a therapy delivery element, simple delivery of an anchor, orprotection of the delivery element during suturing.

Referring to FIG. 1, a general representative environment for animplanted medical device 1 and therapy delivery element 20 are shown.Medical device 1, such as a pacemaker, defibrillator, monitoring device,infusion device, neurostimulator, gastric stimulator, cochlar device, orthe like, is subcutaneously implanted in a patient, for example in anabdominal region. A distal portion 22 of therapy delivery element 20 ispositioned in the patient at a location where therapy is desired to bedelivered. In the embodiment depicted, the distal portion 22 of therapydelivery element 20 is positioned within or along a spinal canal or cordof a patient. However, it will be understood that distal portion 22 oftherapy delivery element 20 may be placed in any desired location toachieve its intended purpose, such as a diagnostic, monitoring, ortherapeutic purpose. In the depicted embodiment, proximal end 24 oftherapy delivery element 20 is operably coupled to medical device 1.

In FIG. 1, an anchor 10 is shown disposed about therapy delivery device20. The depicted anchor 10 contains suture holes 18 for suturing theanchor 10 to tissue of the patient to maintain the position of thetherapy delivery element 20 in proximity to the anchor 10 relative to alocation of the patient.

Therapy delivery element 20 may be a catheter, a lead or lead extension,or the like. In numerous embodiments, therapy delivery element 20 is anelongate element that can deliver therapy, withdraw fluid, sense aparameter, or diagnose a condition. Catheters are typically flexibletubes with a lumen running from the proximal end of the catheter to oneor more delivery regions that are typically located at the distalportion of catheter. A proximal end of a catheter may be coupled to aninfusion medical device 1 such that fluid may be delivered from thedevice 1 via the lumen of the catheter to a target location of a patientvia one or more delivery regions of the catheter.

Leads typically include one or more electrical contacts on a proximalend portion and one or more electrodes on a distal end portion. Thecontacts and electrodes are electrically coupled via insulated wiresrunning through the lead. The contacts may be electrically coupled withan electrical signal generator medical device 1, and signals generatedby the device 1 may be carried along the lead and delivered to thepatient via the electrodes. A lead may be connected to a signalgenerator medical device 1 through a lead extension. An extensiontypically includes one or more contacts at the proximal and distal endportions that are electrically coupled through wires running throughextension. Of course it will be understood that with some systems a leadmay be directly connected to electrical signal generator medical device1 without use of a lead extension. As used hereinafter, “leads” and“lead extensions” are used interchangeably, unless content clearlydictates otherwise.

Referring to FIG. 2, alternative locations for implanting a medicaldevice 1 are shown. As depicted in FIG. 2A, device 1 may be implanted inthe pectoral region 4 of a patient. Alternatively, device 1 may beimplanted in the head 5 of a patient, more specifically behind thepatient's ear (FIG. 2B), in the patient's abdomen 6 (FIG. 2C) or in thepatient's lower back 7 or buttocks (FIG. 2D). Of course, device 1 may beplaced in any medically acceptable location in patient.

While not shown, it will be understood that therapy delivery element 20may be operably coupled to an external device (not shown), as opposed toor in addition to being operably couplable to an implantable device 1.

Referring now to FIG. 3, schematic drawings of various views of anembodiment of an anchor 10 are shown. As shown in the top view of FIG.3A, anchor 10 includes a first opening 12, a second opening 14, and abody portion 11 between the first 12 and second openings 14. The bodyportion 11 is formed of elastomeric material. A lumen 15 (see FIG. 3B,which is a schematic of a cross section taken through line 3 b-3 b ofthe anchor depicted in FIG. 3A) extends through the body portion 11 fromthe first opening 12 to the second opening 14. FIGS. 3C-D are schematicsof head on back and front views from the perspective of lines 3 c and 3d (as shown in FIG. 3A), respectively, providing a view of first 12 andsecond 14 openings.

Referring to FIG. 3B, at least a portion of body 11 is radiallystretchable such that the body portion 11 has a first inner diameter(i.d. 1) (defined by the lumen 15) in a relaxed state and a secondlarger inner diameter (i.d. 2) in a stretched state. As used herein, a“stretched state” of a body portion 11 means a state where body portion11 has a larger inner diameter (defined by lumen 15) than in a relaxedstate, and where the structural integrity of the body portion 11 is notcompromised. A structurally uncompromised body portion 11 will generallybe free of cracks or tears or will be capable of returning substantiallyto its relaxed state (i.e. to an inner diameter prior to radialstretching).

Body portion 11 of anchor 10 may be formed from any suitable elasticmaterial. Examples of suitable elastic materials include copolymers ofstyrene-butadiene, polybutadiene, polymers formed fromethylene-propylene diene monomers, polychloroprene, polyisoprene,copolymers of acrylonitrile and butadiene, copolymers of isobutyldieneand isoprene, polyurethanes and the like. In various embodiments, bodyportion 11 of anchor 10 is formed of material capable of being stretchedup to about 50% or more without substantial loss of structuralintegrity. For example, body portion 11 may be capable of beingstretched up to about 75% or more, 100% or more, 150% or more, or 200%or more. Silicone an example of an elastic material that is generallyexpandable up to about 100% or more without substantial loss ofstructural integrity.

Body portion 11 may be made from the same or different material than theremainder of anchor 10. In various embodiments, the entire anchor 10 ismolded from the same material.

The anchor 10 depicted in FIG. 3 includes retention elements 16. One ormore holes 18 may be formed in a retention element 16 for suturinganchor 10 to tissue of a patient. Retention element 16 may be coupled toor attached to (generally secured to) or may be integrally formed withbody member 11. It will be understood that anchor 10 may include anynumber of retention elements 16. While retention elements are shown asextensions with suture holes 18, it will be understood that anchor 10may include any suitable retention element, such as barbs, tines, or thelike to retain anchor 10 with in a tissue location of a patient.

In various embodiments, body portion 11 of anchor 10 is free of free orsubstantially free of slits or openings other than first 12 and second14 openings. In such embodiments, anchor 10, due to the elastic natureof body member 11, may provide a uniform radially compressive forceagainst a therapy delivery element about which the anchor 10 isdisposed. The absence of slits or other openings may allow for improvedgripping by anchor 10 of a therapy delivery element. It will beunderstood that, in various embodiments, slits or other openings in bodymember 11 may be present, provided that anchor 10 is capable ofgrippingly engaging a therapy delivery element with a desired retentionforce.

Referring now to FIG. 4, schematic drawings of various views of anembodiment of a system including an anchor 10, therapy delivery element20, and an anchor receiving element 30 are shown. The anchor receivingapparatus 30, as depicted, may serve as an anchor deployment apparatus.FIG. 4A depicts a schematic of a top view of a representative system;FIG. 4B is a schematic of a cross section taken through line 4 b-4 b ofFIG. 4A; FIG. 4C is a schematic of an exploded top view of the systemdepicted in FIG. 4A; and FIGS. 4D-E are schematics of head on front andback views of anchor receiving apparatus 30 taken along lines 4 d and 4e, respectively, of FIG. 4C. The anchor receiving apparatus 30 includesan elongate member 36 and a distal opening 32. Elongate member forms acavity or lumen 35 in communication with distal opening 32. Lumen 35 isconfigured to slidably receive proximal portion 24 of therapy deliveryelement 20. In numerous embodiments, anchor receiving element 30includes a proximal opening 34 and lumen 35 extends within elongatemember 36 from the distal 32 to the proximal 34 opening. In suchconfigurations, therapy delivery element 20 may be slid through lumen 35of anchor receiving element 30 such that proximal end 24 of therapydelivery apparatus 20 may extend beyond proximal opening 34 of anchorreceiving element 30 (not shown in FIG. 4).

As depicted in FIGS. 4A-B, anchor 10 is disposed about anchor receivingelement 30. Body member 11 of anchor 10 is disposed about and snugglyengages an outer surface of elongate member 36 of anchor receivingapparatus 30. Elongate member 36 of anchor receiving apparatus 30 has anouter diameter (o.d.) that is larger than the relaxed inner diameter(i.d. 1, see FIG. 3B) defined by lumen 15 of anchor 10 and that issmaller than a stretched inner diameter (i.d. 2, see FIG. 3B) defined bylumen 15 of anchor 10. As such, elastic body portion 11 of anchor 10 maybe radially stretched so that body portion 11 anchor 10 can bepositioned about elongate member 36 of anchor receiving element 30. Theelastic properties of the material forming body member 11 of anchor 10allow body member 11 to snuggly engage the outer surface of elongatemember 36 of the anchor receiving element 30.

With reference to FIG. 4B, elongate body member 36 of anchor receivingapparatus 30 defines a lumen 35. The lumen 35 is configured to slidablyreceive at least a portion of therapy delivery element 20. Therapydelivery element 20 has an outer diameter (o.d.) that is larger than therelaxed inner diameter (i.d. 1, see FIG. 3B) defined by lumen 15 ofanchor 10 and that is smaller than a stretched inner diameter (i.d. 2,see FIG. 3B) defined by lumen 15 of anchor 10. It will be understoodthat therapy delivery element 20 is depicted in FIG. 4B as solid forpurposes of illustration. If therapy delivery element 20 were acatheter, a lumen might be depicts; if therapy delivery element 20 werea lead, an insulated conductor might be depicted; etc.

Referring now to FIG. 5A, which is the same top view of the system shownin FIG.

4A, except that anchor 10 is depicted as being moved distally (indirection of arrow) along elongate body member 36 of anchor receivingapparatus 30. Anchor 10 is slidably moveable off distal end of elongatemember 36 onto therapy delivery device 20, the proximal portion 24 ofwhich is disposed within lumen 35 of anchor receiving element 30 (see,e.g., FIG. 4).

Anchor 10 may be moved distally about elongate member 36 and ontotherapy delivery element 20 through any acceptable manner, including bypushing or pulling. For example, anchor 10 may be manually moved by aphysician's fingers in some embodiments. In some embodiments, anchor 10is pushed with an anchor engagement element; e.g., as discussed belowwith regard to FIGS. 6-8. When body member 11 of anchor 10 is disposedabout therapy delivery element 20, body member snuggly engages at leasta portion of the outer surface of therapy delivery element 20 (see e.g.,FIG. 5C), due to elastic properties of body member 11 and the largerouter diameter of therapy delivery element 20 relative to the relaxedinner diameter of body member 11 defined by lumen 15.

Preferably, anchor body member 11 grips therapy delivery element 20 withsufficient force to prevent movement of anchor 10 relative to therapydelivery element 20 under typical forces experienced when anchor 10 isdisposed about a therapy delivery element 20 and is suture to a patient.In various embodiments, a pull force of about 1 lbf (0.45kilogram-force) or more is required to longitudinally move anchor 10relative to a therapy delivery element 20 that the anchor 10 is disposedabout. For example, a pull force of about 2 pound-force (0.9kilogram-force), about 3 pound-force (1.4 kilogram-force), about 4 poundforce (1.8 kilogram-force), about 5 pound-force (2.3 kilogram-force),about 6 pound-pound force (kilogram-force), or more may be required tolongitudinally move anchor 10 relative to a therapy delivery element 20.It will be understood that, in addition to the elastic properties ofanchor body member 11, other material properties of anchor body 11 andtherapy delivery element 20 may affect the pull force required to moveanchor 10 along therapy delivery element 20. For example, friction dueto various interactions may play a significant role.

In many embodiments, the pull force required to move anchor 10 aboutelongate member 36 of anchor receiving element 30 is less than the pullforce required to move anchor 10 about therapy delivery element 20. Thiscan be accomplished, despite a larger outer diameter of elongate member36 (relative to therapy delivery element 20) by forming elongate member36 from material that decreases frictional interaction between anchor 10and elongate member 36. For example, elongate member 36 may be formed ofhigher durometer material than therapy delivery element 20. By way ofanother example, elongate member 36 may be coated with a material toreduce friction, such ethylene tetrafluoroethylene (ETFE) orpolytetrafluoroethylene (PTFE).

Elongate member 36 of anchor receiving element 30 may be made of anysuitable material. Preferably, elongate member 36 is formed from a rigidmaterial, such as stainless steel, titanium, polycarbonate,polypropylene, or the like.

If anchor 10 is to be sutured to tissue of a patient, it may bedesirable to suture anchor 10 while it is disposed about elongate member36 of anchor receiving element 30 to prevent potential damage to therapydelivery element 20 due to accidental piercing of therapy deliveryelement 20 with a suture needle. Further, anchor receiving element 30,due to the rigidity of elongate member 36, allows for an implantingphysician to maintain the location of anchor 10 with one hand and tosuture anchor 10 with the other hand. If anchor 10 is sutured to tissuewhile disposed about anchor receiving element 30, at least the proximalportion 24 of the therapy delivery element 20 will preferably bedisposed within lumen 35 of elongate member 36 to allow transfer ofanchor 10 from anchor receiving element 30 to therapy delivery element20.

Referring now to FIG. 6, schematic drawings of various views of anembodiment of a system are shown. The system includes an anchorengagement element 40 and an anchor receiving element 30, collectivelyreferred to as an anchor deployment apparatus, an anchor 10 and atherapy delivery element 20. FIG. 6A is a top view of the system; FIG.6B is an exploded top view of the system depicted in FIG. 6B; FIG. 6C isan exploded side view of an embodiment of an anchor engagement element40 and anchor receiving element 30 depicted in FIG. 6A; FIG. 6D is anopposing side view (relative to FIG. 6C) of anchor engagement element40; FIG. 6E is a cross section taken along line 6 e-6 e of FIG. 6A, FIG.6F is a cross section taken along line 6 f-6 f of FIG. 6A; and FIG. 6Gis a an alternative embodiment (relative to FIG. 6E) of a cross sectiontaken along line 6 e-6 e of FIG. 6A. In the embodiment depicted in FIGS.6A-C, anchor receiving element 30 includes a handle 38 at proximal endof elongate member 36. Handle 38 is positioned generally perpendicularto the longitudinal axis of elongate member 36. The anchor receivingelement 30 including handle 38 may contain a proximal opening 34 suchthat lumen 35 extends within elongate member 36 from proximal opening 34to distal opening 32. Handle 38 may be made from the same or differentmaterial than elongate body 36.

Referring to FIGS. 6C-F, anchor engagement element 40 has a proximalopening 42. In proximity to or adjacent to the opening 42, theengagement element 40 contains an anchor engagement feature 41. Theproximal opening 42 is in communication with a channel 45 formed withinthe body of the element 40. The channel 45 runs generally longitudinallywithin at least a proximal portion of engagement element 40. Channel 45is configured such that at least a distal portion of elongate member 36of anchor receiving element 30 may be slidably disposed within channel45. In the depicted embodiment, a larger second channel 46 is formedwithin engagement element 40. The second channel 46 is in communicationwith and an extension of the first channel 45. On a side of engagementelement 40 generally opposing the opening of the second channel 45, aslot 48 is formed within the body of the element 48. The slot 48 and thesecond channel 46 form an uninterrupted passageway through theengagement element 40. The passageway formed by the slot 48 and secondchannel 46 is configured such that handle 38 of anchor receiving element30 is slidably disposable within the passageway. When anchor receivingelement 30 is slidably disposed with anchor engagement element 40, aportion of either side of handle 38 of receiving element 30 extendsbeyond the body of engagement element 40.

Referring to the alternative embodiments depicted in FIG. 6G, channel 45may be tapered inwardly to facilitate insertion of elongate member 36 ofreceiving element 30 into channel 45. In the embodiments depicted inFIGS. 6C, 6E and 6G, enagement feature 41 defines channel 45 and definesopening 42. The radial dimensions of the channel 45 may be larger orsubstantially the same as the outer diameter of the elongate member 36.

Referring to FIG. 7, anchor engagement element 40 may be moved distallyrelative to anchor receiving element 30 (see FIG. 7A) such thatengagement element 40 may force an anchor 10 disposed about elongatebody 36 of receiving element 30 to move distally along the elongate body36 (see FIG. 7B). Continued movement of engagement element 40 distallyrelative to anchor receiving element 30 results in anchor 10 beingtransferred about therapy delivery element 20 (see FIG. 7C). Anchorengagement element 40 may be moved distally relative to anchor receivingelement 30 by pushing engagement element 40 relative to receivingelement 30 or by pulling protruding portions of handle 38 relative toengagement element 40.

Referring to FIG. 8, which is schematic of a side view of a longitudinalsection taken along line 8-8 of FIG. 7B, anchor engagement element 40 isshown in contact with anchor 10. Engagement feature 41 of engagementelement 40 is configured to interact with at least a portion of anchor10 such that engagement feature 41 is capable of moving anchor 10distally along elongate member 36 of anchor receiving element 30 whenengagement element is moved distally relative to elongate member 36 ofanchor receiving element 30. In the embodiment depicted in FIG. 8, andas discussed above with regard to FIGS. 6C, 6E and 6G, engagementfeature 41 defines channel 45 and proximal opening 42 of engagementelement 40. The opening 42 defined by engagement feature 41, in thedepicted embodiments, has dimensions that are smaller than at least aportion of the outer diameter of the body member 11 of the anchor 10.

The anchor deployment tools depicted in FIGS. 6-8 allows for kits havingmultiple anchor receiving elements 30 with preloaded anchors 10 to beprovided with a single anchor engagement element 40. An anchor receivingelement 30 may readily be inserted and withdrawn from engagement element40, allowing for re-insertion of the same or another anchor receivingelement 30. However, embodiments where anchor receiving element 30 isnot removable and reinsertable into anchor engagement element 40 areenvisioned.

Referring now to FIG. 9A, a schematic drawing of a side view of anembodiment of an anchor engagement element 40 is shown. The engagementelement 40 may include one or more stop features 49 protruding into thepassageway formed by slot 48 and second channel 46 (see, e.g., FIGS. 6C,6D and 6F). The stop features 49 are configured and positioned engage ahandle 38 of an anchor receiving element 30 (see, e.g., FIGS. 6-8) and,once engaged, to prevent further proximal movement of handle 38 withinthe opening formed by the slot and second channel of engagement element40. The engagement element 40 may further include a deflecting element47 extending in the passageway formed by the slot 48 and second channel46 and configured to deflect proximal end 24 of therapy delivery element20 (see, e.g., FIG. 8) in embodiments where therapy delivery element 20may extend beyond a proximal portion or handle 38 of anchor receivingelement 30.

Referring to FIG. 9B, in which a schematic drawing of a top view of alongitudinal section taken at line 9 b-9 b of FIG. 9A is shown,deflecting element 47, in the depicted embodiment, is wedge shaped andis capable of causing deflection of an end portion of a therapy deliveryelement that is advanced proximally within a lumen of an anchorreceiving element that is disposed with the anchor engagement element 40to deflect out of a side (e.g., slot 48 or channel 46) of the engagementelement 40 to prevent backing up of therapy delivery element 20 and toallow for relatively proximal movement of therapy delivery element within the context of the systems described herein.

Anchor engagement element 40 may be formed from any suitable material.Preferably the body of engagement element 40 is formed from a rigidmaterial, such as stainless steel, titanium, polycarbonate,polypropylene, or the like. In various embodiments, the body ofengagement element 40 is formed of a polymer having a durometer of about75D or higher. In various embodiments, engagement element 40 is moldedin its entirety.

Referring to FIG. 10, a schematic drawing of a top view ofrepresentative components of a kit is shown. A kit may include an anchorengagement element 40, an anchor 10, and an anchor receiving element 30.The anchor 30 may be preloaded on the anchor receiving element 30. Invarious embodiments, a kit includes two or more anchor receivingelements 30 with preloaded anchors 10. In the depicted embodiment, theanchor receiving elements 30 are insertable, removable and reinsertablein the anchor engagement element 40. An anchor receiving element 30 maybe preloaded in anchor engagement element 40. A kit may further includea therapy delivery element (not shown in FIG. 11).

Anchor 10 may be loaded on anchor receiving element 30 in any mannerthat retains the elastic and therapy delivery element-retainingproperties of the anchor. One suitable manner for placing anchor 10about anchor receiving element 30 is shown in FIGS. 11A-C. As shown inFIG. 11A, anchor 10 may be placed about an insertion element 50 havingproximal 54 and distal 52 ends. A handle (not shown) may be attached toor form a part of a distal portion of insertion element 50. Proximal end54 of insertion element 50 may be inserted into a lumen of anchorreceiving element 30 via proximal opening 32 (see FIG. 11B), and anchor10 may be moved proximally along insertion element 50 and aboutreceiving element 30 until anchor 10 is entirely disposed about elongatemember 36 of receiving element 30 (FIG. 11C). As shown in FIG. 12, whichis schematic cross section taken through line 12-12 of FIG. 11B,insertion element 50 has an outer diameter (o.d.). The outer diameter(o.d.) is larger than the relaxed inner diameter of anchor body 11 andsmaller than a radially stretched inner diameter of anchor body 11 (seeFIG. 3B). The outer diameter (o.d.) of insertion element 50 is sized tocause some radial expansion of anchor body 11 when anchor 10 is disposedabout insertion element 50, but preferably not too much to preventsliding of anchor 10 about insertion element 50. Insertion element 50outer diameter (o.d.) is preferably only slightly smaller than the innerdiameter (i.d.) of elongate body 36 of receiving member 30 so that whenanchor 10 is transferred, via sliding, from insertion element 50 toreceiving element 30, lumen 15 extending through anchor body 11 (seeFIG. 3B) does not undergo substantial radial expansion, as substantialradial expansion of anchor body 11 may make it difficult to transferanchor 10 due to the elastic properties of anchor body 11.

Insertion element 50 is preferably formed from a rigid material, such asstainless steel, titanium, polycarbonate, polypropylene, or the like. Invarious embodiments, insertion element 50 is formed of a polymermaterial having a durometer of about 75D or higher.

Thus, embodiments of ANCHOR AND ANCHOR DEPLOYMENT APPARATUS aredisclosed. One skilled in the art will appreciate that the presentinvention can be practiced with embodiments other than those disclosed.The disclosed embodiments are presented for purposes of illustration andnot limitation, and the present invention is limited only by the claimsthat follow.

What is claimed is:
 1. An anchor deployment apparatus for deploying ananchor about a therapy delivery element, comprising: an anchor receivingelement having an elongate member having a distal opening and a lumenextending proximally in the elongate member from the distal opening, thelumen of the elongate member being configured to slidably receive atleast a portion of a therapy delivery element; and an anchor engagementelement having (i) a first channel in which the elongate member of theanchor receiving element is movable, and (ii) an engagement feature,wherein the engagement feature is configured to engage the anchor whenthe anchor is disposed about the elongate member, and to cause theanchor to move distally along the elongate member when the feature isengaged with the anchor and the elongate member is moved proximallyrelative to the engagement element.
 2. The apparatus of claim 1, whereinthe elongate member of the anchor receiving element further comprises aproximal opening and the lumen extends through the elongate member fromthe proximal opening to the distal opening.
 3. The apparatus of claim 1,further comprising a handle positioned generally perpendicular to alongitudinal axis of the elongate member.
 4. The apparatus of claim 3,wherein the anchor engagement element further comprises: a secondchannel defined in the engagement element and being located distal tothe first channel, wherein the second channel is in communication withan extension of the first channel; and a slot defined in the engagementelement on a generally opposing side of the engagement element relativeto the second channel, wherein the slot and the second channel form apassageway through engagement element, and wherein the handle of theanchor receiving apparatus is slidably disposable within the passagewaysuch that a portion of the handle extends generally perpendicularly outof the channel beyond the engagement element and a portion of the handleextends generally perpendicularly out of the slot beyond the engagementelement.
 5. The apparatus of claim 4, wherein the anchor engagementelement further comprises a stop feature that protrudes into thepassageway formed by the second channel and slot, wherein the stopfeature is configured and positioned to engage the handle of the anchorreceiving apparatus and to prevent the handle from being movedproximally in the passageway once engaged by the stop feature.
 6. Theapparatus of claim 5, wherein the anchor engagement element furthercomprises a deflecting element extending into the passageway formed bythe slot and the second channel and configured to direct a therapydelivery element advanced proximally in the passageway to exit theengagement element via the slot or the second channel.
 7. A kitcomprising: an anchor having (i) a first opening, (ii) a second opening,(iii) a body member disposed between the first and second opening, (iv)a lumen extending though the body member from the first opening to thesecond opening, and (v) a retention element secured to or integrallyformed with the body member, wherein the body member is formed fromelastic material, the lumen is configured to be disposed about at leasta portion of the outer surface of a therapy delivery element, and atleast a portion of the body member has a first inner diameter defined bythe lumen in a relaxed state and a second inner diameter defined by thelumen in a radially stretched state, the first inner diameter beingsmaller than the second inner diameter; and an anchor deploymentapparatus according to claim 1, wherein the elongate member of theanchor receiving element of the anchor deployment apparatus has an outerdiameter larger than the first inner diameter of the portion of thelumen of the anchor and smaller than the second inner diameter of theportion of the lumen of the anchor such that the anchor is disposableabout the elongate member and, when the anchor is disposed about theelongate member, the portion of the lumen of the anchor engages at leasta portion of the elongate member, and wherein the anchor is moveableabout the elongate member.
 8. The kit of claim 7, wherein the anchor ispreloaded about the elongate member of the anchor receiving element. 9.The kit of claim 7, wherein the body member of the anchor is formed fromsilicone.
 10. The kit of claim 7, wherein the therapy delivery elementis a catheter.
 11. The kit of claim 7, wherein the therapy deliveryelement is a lead.